Enoxaparin in Acute Venous Thromboembolic Disease

Phase 4

Completed

• Conditions: Venous Thrombosis
• Interventions: Drug: enoxaparin

• Registration Number: NCT00265993
• Lead Sponsor: Sanofi

Brief Summary

Study objectives :

* To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

• Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors

Exclusion Criteria

• Patients with a history of heparin or warfarin treatment longer than 24 hours,
• Patients requiring thrombolytic treatment,
• Patients having thrombophilia diagnosis,
• Patients with prior deep vein thrombosis or pulmonary emboli evidence,
• Patients with familial bleeding disorder,
• Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month
• Patients with renal failure (serum creatinine concentration > 180 mmol/L or > 2.03 mg/dL),
• Patients with severe hepatic failure
• Patients with history of allergy against heparin and protamine,
• Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
• Patients participating in another clinical study within the last 4 months
• Patients who are pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	enoxaparin	enoxaparin

Primary Outcome Measures

Name	Time	Method
Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.	3 months

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey